Trojan Riviera Personal Lubricant by CHURCH & DWIGHT CO., INC.

A personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

Device Description

The Trojan™ Riviera™ Personal Lubricant is an anhydrous, clear silicone-based personal lubricant with fragrance that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.

The Riviera™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packaged in a carton.

AI/ML Overview

This document describes the premarket notification for the Trojan™ Riviera™ Personal Lubricant (K150886). It focuses on demonstrating substantial equivalence to a predicate device, Trojan™ Tingly Warmth Personal Lubricant (K120706), rather than presenting a study to prove device performance against specific acceptance criteria in the context of an AI/algorithm-based diagnostic device.

Therefore, the following information, typically found in submissions for AI/algorithm-based devices, is not available or applicable in this document:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
Standalone (algorithm only) performance
Type of ground truth used
Sample size for the training set
How the ground truth for the training set was established

However, I can provide information regarding the performed tests and their results for the Trojan™ Riviera™ Personal Lubricant to support its substantial equivalence.

Acceptance Criteria and Device Performance (Biocompatibility & Condom Compatibility)

The "acceptance criteria" here are implied by the "results" of the biocompatibility and condom compatibility tests. The device demonstrates satisfactory performance against these established tests for personal lubricants.

Test Performed	Acceptance Criteria (Implied by results)	Reported Device Performance
Cytotoxicity	Not highly cytotoxic	Mild Reactivity (Grade 2)
Acute Systemic Toxicity	Non-systemically toxic	Non-systemically toxic
Primary Rabbit Skin Irritation	Not a significant irritant	Negligible irritant
Rabbit Vaginal Irritation	Non-irritant	Non-irritant
Rabbit Penile Irritation	Non-irritant	Non-irritant
Guinea Pig Maximum Sensitization	Non-sensitizer	Non-sensitizer
Condom Compatibility (Natural Rubber Latex)	Compatible with condoms	Compatible
Condom Compatibility (Polyisoprene)	Compatible with condoms	Compatible
Viscosity (Shelf-Life)	Satisfactory	Satisfactory
Odor (Shelf-Life)	Satisfactory	Satisfactory
Color (Shelf-Life)	Satisfactory	Satisfactory
Appearance (Shelf-Life)	Satisfactory	Satisfactory
Total Microbial Count (Shelf-Life)	Satisfactory	Satisfactory
Total Yeast and Mold count (Shelf-Life)	Satisfactory	Satisfactory
Absence of Pathogens (Shelf-Life)	Satisfactory	Satisfactory

Study Details:

The document describes non-clinical performance data, biocompatibility review and testing, and safety data to establish substantial equivalence.

Biocompatibility Testing: Performed on the final device in accordance with ISO 10993, "Biological Evaluation of Medical Devices, 2009."
- Sample Size: Not explicitly stated, but typically involves a small number of animals for each test (e.g., rabbits for skin/vaginal/penile irritation, guinea pigs for sensitization).
- Data Provenance: In vivo (animal testing).
- Ground Truth: Established by standard biological evaluation methods and expert interpretation of results according to ISO 10993.
Condom Compatibility Testing: Performed according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms," with a modification to include pre-lubricated and un-lubricated dry condoms.
- Sample Size: Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. The number of individual condoms tested per brand is not specified but would follow ASTM D7761-10 protocols.
- Data Provenance: In vitro (laboratory testing of condoms with the lubricant).
- Ground Truth: Established by the ASTM D7761-10 standard test method, which defines criteria for compatibility.
Shelf-Life Testing: An accelerated stability study was conducted, and a real-time stability study is being performed. Evaluation included viscosity, odor, color, appearance, and microbial evaluation via USP testing.
- Sample Size: Not explicitly stated, but stability studies typically involve multiple samples tested at different time points.
- Data Provenance: In vitro (laboratory testing of the lubricant product over time).
- Ground Truth: Established by industry standards for stability testing (e.g., USP for microbial evaluation) and pre-defined acceptance criteria for physical and chemical properties.

Summary of Unavailable Information (for AI/Algorithm context):

Since this is not an AI/algorithm-based device, the following aspects are irrelevant and therefore not provided in the document:

Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm only) performance
Training set size or ground truth establishment for a training set.
Expert involvement for establishing ground truth for test sets (beyond general expert interpretation in standard lab tests).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 20, 2015

Charles & Dwight Co., Inc. Lisa Burns Senior Regulatory Affairs Specialist 500 Charles Ewing Blvd. Ewing. NJ 08628

Re: K150886 Trade/Device Name: Trojan Riviera Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 22, 2015 Received: June 23, 2015

Dear Lisa Burns,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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II. 510(k) Summary Trojan™ Riviera™ Personal Lubricant

Submitter Name:	Church & Dwight Co., Inc.
Submitter Address:	500 Charles Ewing BoulevardEwing, NJ 08628
Contact Person:	Lisa BurnsSenior Regulatory Affairs SpecialistChurch & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543Tel: (609) 806.1997Fax: (609) 403.7411
Date Prepared:	March 31, 2015
Device Trade Name:	Trojan™ Riviera™ Personal Lubricant
Device Common Name:	Personal Lubricant
Product Code:	NUC - Condom (21 CFR § 884.5300)
Classification:	Class II
Predicate Device:	Trojan™ Tingly Warmth Personal Lubricant (K120706)
Intended Use:	A personal lubricant for penile and/or vaginal application,intended to lubricate and moisturize, to enhance the ease andcomfort of intimate sexual activity and supplement the body'snatural lubrication. The product is compatible with naturalrubber latex and polyisoprene condoms. Not compatible withpolyurethane or other condoms.

Device Description:

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Technological Characteristics:

There is no difference in the fundamental technological characteristics of Riviera™ Personal Lubricant and the predicate Trojan™ Tingly Warmth Personal Lubricant (K120706). The 510(k)-subject device contains a similar silicone base as the legally marketed predicate, and the addition of fragrance does not raise new questions of safety or effectiveness.

Biocompatibility:

Biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009.

Test Performed	Results
Cytotoxicity	Mild Reactivity (Grade 2)
Acute Systemic Toxicity	Non-systemically toxic
Primary Rabbit Skin Irritation	Negligible irritant
Rabbit Vaginal Irritation	Non-irritant
Rabbit Penile Irritation	Non-irritant
Guinea Pig Maximum Sensitization	Non-sensitizer

Condom compatibility:

Condom Compatibility Testing was performed with Riviera™ Personal Lubricant according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" with a modification to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. Condoms made from polyisoprene were included to represent an alternative to natural rubber latex that may be used with the 510(k)-subject lubricant.

Condom compatibility testing demonstrates that Riviera™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.

Shelf Life:

Riviera™ Personal Lubricant has a two year shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor, color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count, Total Yeast and Mold count, and Absence of Pathogens. The results were satisfactory for all parameters.

A real-time stability study is being performed in order to verify results.

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Substantial Equivalence:

Based on non-clinical performance data, biocompatibility review and testing and safety data, Riviera™ Personal Lubricant is substantially equivalent to the predicate device, Trojan™ Tingly Warmth Personal Lubricant in technology, intended use, safety and effectiveness.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.